Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain
| ISRCTN | ISRCTN80764175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80764175 |
| Protocol serial number | HTA 96/40/07 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Kate Thomas
Scientific
Scientific
School of Health Care
University of Leeds
Baines Wing
Leeds
LS2 9UT
United Kingdom
| Phone | +44 (0)113 343 5635 |
|---|---|
| k.thomas@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A pragmatic, two parallel group, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | YACBAC |
| Study objectives | Acupuncture is widely used in NHS primary care for a variety of pain related conditions. Evidence of the clinical cost effectiveness of its use in this context is sparse, particularly relating to its longer term effectiveness in the relief of chronic pain. More research is needed to ensure the appropriate use of NHS resources. The proposed study is a pragmatic randomised controlled trial (n=200) to evaluate the longer term clinical and economic benefits of offering acupuncture to patients assessed as suitable for primary care management with reported low back pain of more than four weeks duration. The study aims to test the hypothesis that a population of patients offered traditional acupuncture for chronic low back pain gain as much or more relief from pain as those offered normal management only by their GP, for equal or less cost. The study aims to provide appropriate evidence for future NHS purchasing decisions. The research is a collaboration between a University research department, and accredited Acupuncture College and Research Foundation and a GP consortium. It builds on previously completed work, including a pilot of the outcome measures proposed and the feasibility of the GP referral service to traditional acupuncture treatment. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic low back pain |
| Intervention | 1. Traditional Chinese acupuncture, up to 10 treatments 2. Standard care offered by GP only |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Relief of chronic pain |
| Key secondary outcome measure(s) |
Secondary outcomes included the McGill Present Pain Index (PPI), Oswestry Pain Disability Index (ODI), all other SF-36 dimensions, medication use, pain-free months in the past year, worry about back pain, satisfaction with care received, and safety and acceptability of acupuncture care. |
| Completion date | 11/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Patients with low back pain. Age 20-65 years with low back pain or sciatica, greater than 4 weeks and less than 12-months pain this episode |
| Key exclusion criteria | Past spinal surgery, severe or progressive motor weakness or central disc prolapse, possible spinal pathology (eg carcinoma) |
| Date of first enrolment | 12/04/1999 |
| Date of final enrolment | 11/05/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Health Care
Leeds
LS2 9UT
United Kingdom
LS2 9UT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | main results | 23/09/2006 | Yes | No | |
| Other publications | HTA monograph | 01/08/2005 | Yes | No | |
| Other publications | cost effectiveness analysis | 23/09/2006 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
